In the 2-year AFFIRM pivotal trial:

Relapsing MS patients received 300 mg TYSABRI IV every 28 days (n=627) or placebo (n=315). Patients with PPMS, SPMS, and PRMS were excluded.

83% of patients taking TYSABRI had no sustained physical disability progression for 12 weeks vs 71% with placebo (primary endpoint: 17% vs 29%; p<0.001)1,2

HEALTH-RELATED QUALITY OF LIFE WAS ANALYZED IN PATIENTS AFTER TREATMENT WITH TYSABRI

In an exploratory analysis of the pivotal trials:

TYSABRI patients reported improved health-related quality of life (HRQoL) scores3

Study description: A retrospective, exploratory analysis of the pivotal trials was performed to report the effects of TYSABRI on HRQoL as measured by the Short Form-36 (SF-36). Annualized relapse rate (ARR) was measured at 3-month intervals.3,a

  • The SF-36 is a widely used, general HRQoL instrument that contains 36 items used to assess patients’ health status and its impact on their lives

aThe SF-36 is a widely used, general HRQoL instrument that contains 36 items that assess patients’ health status and its impact on their lives. SF-36 HRQoL results are patient-reported.3

Study limitations:

  • Results are exploratory outcomes of the AFFIRM trial, and a number of calculations were made to evaluate data trends; therefore, marginal p values should be interpreted with caution
  • The standard minimally important difference cutoff of 5 points was derived from a disease-free population, thus it may be preferable to establish a minimally important difference in patients with RMS
  • Significance level for testing the difference between treatment groups was set at 0.05 with no correction for multiple analyses
  • HRQoL measures were completed at baseline, and Weeks 24, 52, and 104. Earlier measures would have allowed better understanding of when patients might expect improvement after they start therapy, and testing between Weeks 52 and 104 would have provided insight into the stability of HRQoL benefits during the second year of treatment
  • HRQoL for 9% (8% TYSABRI, 10% placebo) of patients who withdrew from the study was not known. Reasons for discontinuation of TYSABRI were not collected 

HRQoL improvements were observed with TYSABRI as early as 6 months and sustained out to 2 years3

Adapted from the American Medical Association by Wiley-Liss, Inc.

Bold rows with highlighted values: statistically significant compared with placebo.

Baseline scores and changes from baseline at Weeks 24, 52, and 104 are shown for all SF-36 scales.

bp<0.01.

cp<0.05.

dp<0.001.

Physical Function score was significantly greater at 6 months, 1 year, and 2 years (p <0.01), and there were significant improvements in 6 of 8 individual HRQoL scales

Patients treated with TYSABRI reported mean improvements relative to placebo in a majority of scales by Year 2 (Week 104)3

Patients taking TYSABRI achieved significant improvements in the Physical Function, Role-Physical, General Health, Vitality, Social Function, and Role-Emotional scales at 2 years3

This study was funded by Biogen.